Data updated: May 26, 2026
Imlygic (talimogene laherparepvec)
Approved 2015-10-26
1
Indication
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-10-26
- Patent Cliff
- 2022
- Routes
- Intralesional
- Dosage Forms
- For Injection
Imlygic Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2015 to 2015
Oct 2015 ORIGINAL
Update · CBER biologic (Purple Book)
What Imlygic Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 2015)
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Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02923778 | NCI-2016-01461 NCI-2016-01461, MC1678 | Ph 2 | active not recruiting | Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery |
| NCT02978625 | NCI-2016-01804 NCI-2016-01804, CINJ #091701 | Ph 2 | active not recruiting | Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers |
| NCT07102394 | IRB00482551 | Ph 1 | recruiting | Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1 |
| NCT02779855 results posted | MCC-18621 | Ph 1, Ph 2 | completed | Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer |
| NCT04599062 results posted | 201504731 (8 milliliter dose) | Ph 1, Ph 2 | active not recruiting | TVEC and Preop Radiation for Sarcoma (8 ml Dose) |
| NCT04163952 results posted | Pro2018002628 NCI-2019-06083, Pro2018002628 | Ph 1 | terminated | Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin |
| NCT06660810 | 202402722 | Ph 2 | active not recruiting | Neoadjuvant Intralesional Injection of Talimogene Laherparepvec |
| NCT02965716 results posted | NCI-2016-01698 NCI-2016-01698, S1607 | Ph 2 | active not recruiting | Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma |
| NCT03554044 | 17753 NCI-2018-00652 | Ph 1 | completed | T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer |
| NCT04068181 results posted | 20180115 2019-001906-61 | Ph 2 | completed | Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07). |
| NCT03086642 | AAAQ9966 1R01FD006108-01 | Ph 1 | completed | Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer |
| NCT03663712 TEMPO results posted | Pro00086917 | Ph 1 | completed | Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies |
| NCT02509507 MASTERKEY-318 results posted | 20140318 2014-005386-67 | Ph 1, Ph 2 | completed | Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611 |
| NCT02453191 results posted | 201504731 (4 milliliter dose) | Ph 1, Ph 2 | completed | TVEC and Preop Radiation for Sarcoma (4 ml Dose) |
| NCT03300544 results posted | NCI-2016-01844 NCI-2016-01844, NCI10058 | Ph 1 | terminated | Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer |
| NCT01740297 results posted | 20110264 2012-000307-32 | Ph 1, Ph 2 | completed | Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma |
| NCT03256344 results posted | 20140299 | Ph 1 | completed | Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases |
| NCT03842943 | 181095 | Ph 2 | recruiting | Neoadjuvant Combination Immunotherapy for Stage III Melanoma |
| NCT02756845 results posted | 20110261 2015-003645-25 | Ph 1 | completed | Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors |
| NCT04185311 | 18-000427 NCI-2018-01410, Glaspy BMS CA209-9ET Breast | Ph 1 | terminated | Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted |
| NCT03064763 results posted | 20140270 | Ph 1 | completed | Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma |
| NCT02211131 results posted | 20110266 2014-001146-13 | Ph 2 | completed | Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma |
| NCT02658812 results posted | 2014-0034 NCI-2016-00199, 2014-0034 | Ph 2 | terminated | Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery |
| NCT02263508 MASTERKEY-265 results posted | 20110265 2014-000185-22, KEYNOTE-034 | Ph 3 | terminated | Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma |
| NCT02366195 TVEC-325 results posted | 20120325 2013-005552-15 | Ph 2 | completed | Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma |
| NCT02626000 MASTERKEY232 results posted | 20130232 20130232 / KEYNOTE-137, 2015-003011-38 | Ph 1 | completed | Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137) |
| NCT03430687 | 15521 NCI-2018-00109, 15-17558 | Ph 1 | withdrawn | Talimogene Laherparepvec in Treating Patients With Non-Muscle Invasive Bladder Transitional Cell Carcinoma |
| NCT02014441 results posted | 20120324 | Ph 2 | completed | Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec |
| NCT00769704 results posted | 005/05 20110263, 2008-006140-20 | Ph 3 | completed | Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma |
| NCT01161498 results posted | 006/09 20110130 | Ph 3 | terminated | Study of Safety and Efficacy of Talimogene Laherparepvec With Cisplatin and Radiotherapy for Treatment of Locally Advanced Head and Neck Cancer |
| NCT01368276 results posted | 005/05-E 2010-021070-11, 20110279 | Ph 3 | completed | An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma |
| NCT02574260 results posted | 002/03-E | Ph 2 | completed | An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Imlygic FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.